CMC Regulatory Affairs Senior/Consultant - Small Molecules & Biologics

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client’s investigational, new, and marketed biologic and small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.

Key Responsibilities

Strategic CMC Leadership

•             Provide regulatory strategy input for biologics and small molecules (previous experience with drug-device combination products is a plus)

•             Support regulatory leads in developing contingency plans for CMC-related scenarios

•             Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads

Submission & Documentation Excellence

•             Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions

•             Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes

Cross-Functional Collaboration

•             Partner with manufacturing, quality, and external organizations to address CMC-related issues

•             Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers

•             Support planning and execution of Health Authority meetings, including mock sessions

Process Optimization & Innovation

•             Identify and implement process improvements to enhance regulatory efficiency and readiness

•             Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions

•             Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer

Regulatory Systems & Reporting

•             Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus

•             Ensure audit readiness and version control through meticulous documentation and system management

Qualifications

Experience & Expertise

•             4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant

•             Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)

•             In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for biologics and small molecules

•             Familiarity with upstream/downstream biologic processes and analytical methods

Skills & Attributes

•             Strategic and proactive mindset with strong operational execution

•             Excellent analytical, problem-solving, and negotiation skills

•             Effective communicator with strong interpersonal, presentation, and leadership abilities

•             Ability to manage multiple projects independently in a matrixed, multicultural environment

•             Proficiency in Microsoft Office Suite and regulatory systems

Education

•             Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field

•             Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred

•             RAC certification is a plus

Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the sched